Apparatus for approximating sutures in cardiac procedures

ABSTRACT

Described herein are devices for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.16/012,195, filed Jun. 19, 2018, which claims the benefit of U.S.Application No. 62/521,784, filed Jun. 19, 2017, the disclosures all ofwhich is incorporated by reference for all purposes.

BACKGROUND Field

Some embodiments described herein relate to methods and apparatus forjoining two or more sutures together during surgical procedures, such ascardiac valve repairs, and more particularly, methods and apparatus forperforming minimally invasive mitral or tricuspid valve repairs.

Description of Related Art

Various disease processes can impair the proper functioning of one ormore of the valves of the heart. These disease processes includedegenerative processes (e.g., Barlow's disease, fibroelasticdeficiency), inflammatory processes (e.g., rheumatic heart disease), andinfectious processes (e.g., endocarditis). Additionally, damage to theventricle from prior heart attacks (e.g., myocardial infarctionsecondary to coronary artery disease) or other heart diseases (e.g.,cardiomyopathy) can distort the geometry of the heart causing valves inthe heart to dysfunction. The vast majority of patients undergoing valvesurgery, such as mitral valve surgery, suffer from a degenerativedisease that causes a malfunction in a leaflet of the valve, whichresults in prolapse and regurgitation.

Generally, a heart valve may malfunction in two different ways. Onepossible malfunction, valve stenosis, occurs when a valve does not opencompletely and thereby causes an obstruction of blood flow. Typically,stenosis results from buildup of calcified material on the leaflets ofthe valves causing the leaflets to thicken, thereby impairing theirability to fully open and permit adequate forward blood flow.

Another possible malfunction, valve regurgitation, occurs when theleaflets of the valve do not close completely thereby allowing blood toleak back into the prior chamber when the heart contracts. There arethree mechanisms by which a valve becomes regurgitant or incompetent;they include Carpentier's type I, type II and type III malfunctions. ACarpentier type I malfunction involves the dilation of the annulus suchthat the area of the valve orifice increases. The otherwise normallyfunctioning leaflets do not have enough surface area to cover theenlarged orifice and fail to form a tight seal (e.g., do not coaptproperly) causing regurgitation. Included in a type I mechanismmalfunction are perforations of the valve leaflets, as in endocarditis.A Carpentier's type II malfunction involves prolapse of a segment of oneor both leaflets above the plane of coaptation. This is the mostcommonly treated cause of mitral regurgitation and is often caused bythe stretching or rupturing of chordae tendineae normally connected tothe leaflet. A Carpentier's type III malfunction involves restriction ofthe motion of one or more leaflets such that the leaflets are abnormallyconstrained below the level of the plane of the annulus. Leafletrestriction can be caused by rheumatic heart disease (Ma) or dilation ofthe ventricle (IIIb).

Mitral valve disease is the most common valvular heart disorder, withnearly 4 million Americans estimated to have moderate to severe mitralvalve regurgitation (“MR”), with similar numbers of individuals impactedoutside of the United States. MR results in a volume overload on theleft ventricle which in turn progresses to ventricular dilation,decreased ejection performance, pulmonary hypertension, symptomaticcongestive heart failure, atrial fibrillation, right ventriculardysfunction and death. Successful surgical mitral valve repair restoresmitral valve competence, abolishes the volume overload on the leftventricle, improves symptom status, and prevents adverse leftventricular remodeling. While generally safe and effective, conventionalopen-heart operations are invasive, result in significant disability,and require extended post-procedure recovery. Patients routinely spendfive to seven days in the hospital and often are not able to return tonormal daily activities for a month or more.

Malfunctioning valves may either be repaired or replaced. Repairtypically involves the preservation and correction of the patient's ownvalve. Replacement typically involves replacing the patient'smalfunctioning valve with a biological or mechanical substitute.Typically, replacement is preferred for stenotic damage sustained by theleaflets because the stenosis is irreversible. The mitral valve andtricuspid valve, on the other hand, are more prone to deformation.Deformation of the leaflets, as described above, prevents the valvesfrom closing properly and allows for regurgitation or back flow of bloodfrom the ventricle into the atrium, which results in valvularinsufficiency. Deformations in the structure or shape of the mitralvalve or tricuspid valve are often repairable.

In many instances of mitral valve regurgitation, repair is preferable tovalve replacement. Mitral valve replacement operations have a 2× higherrisk of operative mortality (risk standardized mortality 1.65% vs.2.96%), 2× higher risk of stroke per year (1.15% vs. 2.2%) and a 10×higher risk of infection per year (0.1% vs. 1.0%). Patients who receivea quality mitral valve repair operation do not require anticoagulationand rarely require reoperation. This is in stark contrast to mechanicalvalve replacement which mandates lifelong anticoagulation andbioprosthetic valve replacement with the eventual certainty ofprosthetic valve dysfunction and reoperation. Compared to mitral valvereplacement, mitral valve repair results in improved left ventricularfunction and has superior long-term survival. Therefore, an improperlyfunctioning mitral valve or tricuspid valve is ideally repaired, ratherthan replaced. Because of the complex and technical demands of thecurrent repair procedures, however, the mitral valve is still replacedin approximately one third of all mitral valve operations performed inthe United States.

Studies suggest that Carpentier type II malfunction, often referred toas “degenerative,” “primary” or “organic” MR, accounts for as much as60% of MR. Resectional mitral valve repair techniques, initiallydescribed by Dr. Carpentier, involve cutting out (resecting) a sectionof the prolapsed leaflet tissue, stitching the remaining tissue togetherand implanting an annuloplasty ring around the annulus. Removing aportion of one or both of the mitral valve leaflets during such aresectional repair decreases the available leaflet tissue to seal themitral orifice. To accommodate the decrease caused by the resectionalrepair, in many instances, an annuloplasty ring must be implanted todecrease the size of the mitral orifice.

Implanting an annuloplasty ring introduces various risks. For example,implanting an annuloplasty ring can increase pressure gradients acrossthe valve. Further, an annuloplasty ring can lead to infection and/orannuloplasty ring dehiscence—a well-documented failure mode of valverepair surgery. Implanting an annuloplasty ring can further impact thedynamic nature of the mitral valve annulus throughout the cardiac cycle.In a healthy person, for example, the mitral valve annulus relaxesduring diastole and contracts with the rest of the left ventricle duringsystole, causing the annulus to expand and contract as the heart beats.Implanting an annuloplasty ring can interfere with such normalfunctioning of the heart. To combat such interference, flexibleannuloplasty rings and partial bands have been developed to minimize theimpact a rigid or complete annuloplasty ring can have on the dynamicmovement of the mitral annulus. To avoid the aforementionedcomplications and risks, an effective mitral valve repair procedure thateliminated the need for an annuloplasty ring is desirable, particularlya repair that can be performed minimally-invasively and off-pump inwhich implanting an annuloplasty ring would be present technicalchallenges.

More recently many surgeons have moved to a “non-resectional” repairtechnique where artificial chordae tendineae (“cords”) made of expandedpolytetrafluoroethylene (“ePTFE”) suture, or another suitable material,are placed in the prolapsed leaflet and secured to the heart in the leftventricle, normally to the papillary muscle. Because the native leaflettissue is maintained in non-resectional repairs, they often result in alarger surface of coaptation between the posterior and anterior mitralvalve leaflets, but properly sizing the cords on a flaccid heart can bevery challenging, especially for the low volume mitral valve surgeon.Implanting an annuloplasty ring with such non-resectional repairs on astopped heart is currently the standard of care. Implanting anannuloplasty ring in a beating heart repair is technically challengingand rarely done in practice due in large part to the costs associatedwith two separate procedures (e.g., cordal repair and annuloplasty). Adevice that can quickly and easily perform a beating-heart cordal repairwhile also addressing the mitral annulus would be a major advancement.

Carpentier type I malfunction, sometimes referred to as “secondary” or“functional” MR, is associated with heart failure and affects between1.6 and 2.8 million people in the United States alone. Studies haveshown that mortality doubles in patients with untreated mitral valveregurgitation after myocardial infarction. Unfortunately, there is nogold standard surgical treatment paradigm for functional MR and mostfunctional MR patients are not referred for surgical intervention due tothe significant morbidity, risk of complications and prolongeddisability associated with cardiac surgery. Surgeons use a variety ofapproaches ranging from valve replacement to insertion of an undersizedmitral valve annuloplasty ring for patients suffering from functional MRand the long-term efficacy is still unclear. In a randomized study ofon-pump, open-heart mitral valve repair versus mitral valve replacementfor functional MR, mitral valve replacement had a similar mortality rateand resulted in significantly less recurrent MR after one year and twoyears. According to some, a subsequent sub-analysis of subjects in therepair group suggests that the people who received a “good repair” didbetter than the replacement group but that when the repair arm wascompared to mitral valve replacement, the “bad repairs” caused thereplacement arm to perform better. Either way, there is a need forbetter treatment options for functional MR. Less invasive,beating-heart, transcatheter repair and replacement technologies are ofparticular interest because they do not require cardiopulmonary bypass,cardioplegia, aortic cross-clamping or median sternotomy.

Dr. Alfieri has demonstrated the benefit of securing the midpoint ofboth leaflets together creating a double orifice valve in patients withMR known as an “edge-to-edge” repair or an Alfieri procedure. Theability to combine a neochordal repair with an edge-to-edge repair indegenerative MR patients with a dilated annulus and who do not receivean annuloplasty ring because the repair is done in a minimally-invasive,off-pump procedure, has particular promise. Further, performing afacilitated edge-to-edge repair in which sutures placed on both theposterior and anterior leaflets are secured together and then pulledtoward the base of the heart has the potential to improve the overallrepair. Performing a facilitated edge-to-edge procedure in aminimally-invasive beating heart procedure is a further advancement.Further, in addition to or instead of creating the edge-to-edgerelationship, to promote a larger surface of coaptation between theanterior and posterior leaflets, and thereby to promote proper valvefunction and limit or prevent undesirable regurgitation, suturesextending from the leaflets can be secured together to pull or tootherwise move the posterior annulus towards the anterior leaflet and/orthe anterior annulus towards to posterior leaflet. This reduces thedistance between the anterior annulus and the posterior annulus (or theseptal-lateral distance) (e.g., by about 10%-30%). Approximating theanterior annulus and the posterior annulus in this manner can decreasethe valve orifice, and thereby decrease, limit, or otherwise preventundesirable regurgitation.

Regardless of whether a replacement or repair procedure is beingperformed, conventional approaches for replacing or repairing cardiacvalves are typically invasive open-heart surgical procedures, such assternotomy or thoracotomy, which require opening up of the thoraciccavity so as to gain access to the heart. Once the chest has beenopened, the heart is bypassed and stopped. Cardiopulmonary bypass istypically established by inserting cannulae into the superior andinferior vena cavae (for venous drainage) and the ascending aorta (forarterial perfusion), and connecting the cannulae to a heart-lungmachine, which functions to oxygenate the venous blood and pump it intothe arterial circulation, thereby bypassing the heart. Oncecardiopulmonary bypass has been achieved, cardiac standstill isestablished by clamping the aorta and delivering a “cardioplegia”solution into the aortic root and then into the coronary circulation,which stops the heart from beating. Once cardiac standstill has beenachieved, the surgical procedure may be performed. These procedures,however, adversely affect almost all of the organ systems of the bodyand may lead to complications, such as strokes, myocardial “stunning” ordamage, respiratory failure, kidney failure, bleeding, generalizedinflammation, and death. The risk of these complications is directlyrelated to the amount of time the heart is stopped (“cross-clamp time”)and the amount of time the subject is on the heart-lung machine (“pumptime”).

Thus, there is a significant need to perform mitral valve repairs usingless invasive procedures while the heart is still beating. Accordingly,there is a continuing need for new procedures and devices for performingcardiac valve repairs, such as mitral valve repair, which are lessinvasive, do not require cardiac arrest, and are less labor-intensiveand technically challenging.

SUMMARY

Apparatus and methods for repairing a tissue by remotely securing two ormore sutures together are described herein. In some embodiments,apparatus and methods for performing a non-invasive procedure to repaira cardiac valve are described herein. In some embodiments, apparatus andmethods are described herein for repairing a mitral valve using anedge-to-edge procedure (also referred to as an Alfieri procedure) tosecure the mitral valve leaflets.

In a first aspect, the present disclosure provides a method for twistingsutures together to approximate anchor implants attached to targetedtissue. The method includes attaching two or more cords to targetedtissue, individual cords including a distal anchor implant and a sutureextending proximally from the distal anchor implant. The method alsoincludes securing proximal end portions of the two or more sutures to atwister device. The method also includes operating the twister device tocause the two or more sutures to intertwine. The method also includesreceiving feedback from a visualization system, the feedback includingan approximation of the targeted tissue. The method also includesanchoring the proximal end portions of the two or more sutures toprevent unwinding of the two or more sutures.

In some embodiments of the first aspect, the targeted tissue is within atargeted region and the twister device is operated outside of thetargeted region. In further embodiments of the first aspect, thetargeted region is the heart. In further embodiments of the firstaspect, anchoring the proximal end portions of the two or more suturesincludes securing the proximal end portions to an external wall of theheart. In further embodiments of the first aspect, the method furtherincludes inserting a portion of the twister device into a valveintroducer that provides access to the targeted tissue within thetargeted region.

In some embodiments of the first aspect, the targeted tissue includes aleaflet of a mitral valve. In further embodiments of the first aspect,the targeted tissue includes a posterior leaflet. In further embodimentsof the first aspect, the targeted tissue includes an anterior leaflet.

In some embodiments of the first aspect, the method further includesadjusting a tension of the two or more sutures. In further embodimentsof the first aspect, adjusting a tension of the two or more suturesoccurs simultaneously with operating the twister device to cause the twoor more sutures to intertwine.

In some embodiments of the first aspect, operating the twister device tocause the two or more sutures to intertwine results in a point ofintersection that approaches the targeted tissue to change a forcevector on the two or more cords attached to the targeted tissue.

In a second aspect, the present disclosure provides a twister devicethat includes a body; a suture management component coupled to the body,the suture management component having one or more features to receiveend portions of two or more sutures and to secure the received sutureend portions to the body; and a twisting component coupled to the body,the twisting component configured to rotate the suture managementcomponent to intertwine the two or more sutures.

In some embodiments of the second aspect, the suture managementcomponent includes two or more tie knobs. In further embodiments of thesecond aspect, the suture management component further includes suturelocks configured to releasably engage with the two or more tie knobs tosecure the suture end portions to the two or more tie knobs.

In some embodiments of the second aspect, the suture managementcomponent includes a rotating spin lock. In further embodiments of thesecond aspect, the rotating spin lock includes an adjustable leak proofseal configured to grip the suture end portions and to prevent backflowof fluids during operation of the twister device.

In some embodiments of the second aspect, the twister device furtherincludes a side port configured to receive a fluid to prevent blood fromclotting.

In some embodiments of the second aspect, the body forms a lumenconfigured to allow two or more sutures to pass therethrough. In furtherembodiments of the second aspect, the suture management component isformed on a proximal side of the body and the lumen runs from theproximal side to the distal side of the body. In further embodiments ofthe second aspect, the suture management component is configured tosecure the received suture end portions that are routed from the distalside to the proximal side of the body through the lumen.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features have been described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment. Thus, the disclosed embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 1C, and 1D illustrate schematically an example method anddevice for approximating tissues using a twister device disposed outsidea target region.

FIG. 2 illustrates a cut-away anterior view of a heart, showing theinternal chambers, valves and adjacent structures.

FIG. 3A illustrates a top perspective view of a healthy mitral valvewith the mitral leaflets closed.

FIG. 3B illustrates a top perspective view of a dysfunctional mitralvalve with a visible gap between the mitral leaflets.

FIG. 3C illustrates a cross-sectional view of a heart illustrating amitral valve prolapsed into the left atrium.

FIG. 3D illustrates an enlarged view of the prolapsed mitral valve ofFIG. 3C.

FIG. 4 illustrates a cross-sectional view of a heart showing the leftatrium, right atrium, left ventricle, right ventricle and the apexregion.

FIG. 5 illustrates an example method for twisting sutures together toapproximate distal anchors attached to tissue.

FIGS. 6A, 6B, 6C, and 6D illustrate block diagrams of example twistdevices that can be used to perform the example method of FIG. 5 .

FIG. 7 illustrates a schematic illustration of a mitral valve withleaflets that are separated by a gap.

FIGS. 8A and 8B illustrate a perspective view and a side view,respectively, of an example twister device.

FIGS. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, 9I, 9J, 9K, 9L, and 9M illustratean example method using an example twister device to approximate twomodel valve leaflets disposed within a model heart.

FIGS. 10A, 10B, 10C, 10D, 10E, 10F, 10G, 10H, 10I, 10J, and 10Killustrate an example method using an example twister device toapproximate two model valve leaflets disposed within a model heart.

FIGS. 11A, 11B, 11C, 11D, 11E, 11F, 11G, 11H, 11I, 11J, 11K, 11L, 11M,11N, and 11O illustrate an example method using an example twisterdevice to approximate two model valve leaflets disposed within a modelheart.

FIGS. 12A and 12B illustrate another example twister device with arotating spin lock.

FIG. 13 illustrates a cross-sectional view of a heart having implant andinterlaced chords deployed therein and coupled to the example twisterdevice of FIGS. 11A-11O.

DETAILED DESCRIPTION

The headings provided herein, if any, are for convenience only and donot necessarily affect the scope or meaning of the claimed invention.

Overview

During conventional, on-pump cardiac operations the heart is stopped andthe doctor has vision of and direct access to the internal structures ofthe heart. In conventional operations, doctors perform a wide range ofsurgical procedures on a defective valve. In degenerative mitral valverepair procedures, techniques include, for example and withoutlimitation, various forms of resectional repair, chordal implantation,and edge-to-edge repairs. Clefts or perforations in a leaflet can beclosed and occasionally the commissures of the valve sutured to minimizeor eliminate MR. While some devices have been developed to replicateconventional mitral valve procedures on a beating heart (see, e.g., PCTApplication No. PCT/US2012/043761 (published as WO 2013/003228 A1)(referred to herein as “the '761 PCT Application”)) there is a need toexpand the “toolbox” available to doctors during these minimallyinvasive procedures.

The ability to remotely (e.g., from outside the heart during a cardiacvalve repair) and adjustably secure two or more otherwise separatestrands of suture together within a body has wide ranging applications.One application, for example, is in minimally-invasive, beating-heart,cardiac procedures. The ability to remotely secure two or more suturestrands together while the heart is beating should dramatically expandthe utility of the devices that have been used in cardiac operations todate.

In some embodiments, a method for repairing tissue includes inserting adelivery device, such as a delivery device described in the '761 PCTApplication and/or in International Patent Application No.PCT/US2016/055170 (published as WO 2017/059426A1) (referred to herein as“the '170 PCT Application”), the entire disclosure of each of which isincorporated herein by reference, into a body and extending a distal endof the delivery device to a proximal side of the tissue. Advancement ofthe delivery device may be performed in conjunction with sonography ordirect visualization (e.g., direct transblood visualization), and/or anyother suitable remote visualization technique. With respect to cardiacprocedures, for example, the delivery device may be advanced inconjunction with transesophageal (TEE) guidance or intracardiacechocardiography (ICE) guidance to facilitate and to direct the movementand proper positioning of the device for contacting the appropriatetarget cardiac region and/or target cardiac tissue (e.g., a valveleaflet, a valve annulus, or any other suitable cardiac tissue). Typicalprocedures for use of echo guidance are set forth in Suematsu, Y., J.Thorac. Cardiovasc. Surg. 2005; 130:1348-56 (“Suematsu”), the entiredisclosure of which is incorporated herein by reference.

A piercing portion of the delivery device can be used to form an openingin the tissue, through which the distal end of the delivery device canbe inserted. The delivery device can be used to form or deliver animplant (e.g., a distal anchor) to the distal side of the tissue. Thedelivery device can be used in this manner to deliver two or moreimplants to the distal side of the tissue. The implants can be deliveredto a single tissue (e.g., a posterior mitral valve leaflet), or one ormore implants can be delivered to a first tissue (e.g., a posteriormitral valve leaflet), and one or more other implants can be deliveredto a second tissue (e.g., an anterior mitral valve leaflet, a mitralvalve annulus, or any other suitable tissue) separate from the firsttissue. The delivery device can then be withdrawn, and suture portionsextending from the implants can extend to a location (e.g., an outsidesurface of the heart or other suitable organ) remote from the tissue(s).The remote suture portions can then be coupled to a device that can beoperated to twist the remote suture portions together. Advantageously,using the methods and apparatus disclosed herein, introducing additionalforeign objects, such as, for example, a securing device, to an area(e.g., the heart) within which the tissues are located, can be avoided.For example, in a non-invasive cardiac procedure to repair cardiactissue(s) within the heart, the twister device can remain outside theheart and can be used to selectively and remotely secure the sutureportions extending form the implants and to selectively, reversibly, andcontrollably approximate the tissue(s).

FIGS. 1A, 1B, 1C, and 1D illustrate schematically an example method andexample device for approximating tissues T1, T2. The method uses atwister device 140 disposed outside a target region TR. As illustratedin FIG. 1A, both a suture portion 132 extending from a first implant 131and a suture portion 134 extending from a second implant 131′ can extendto a location (e.g., an outer surface of the heart) remote from thetissues T1, T2 where the suture portions 132, 134 are coupled to thetwister device 140. With each suture portion 132, 134 coupled to thetwister device 140 remote from the tissues T1, T2, the twister device140 (or a portion or component of the twister device 140) can be rotatedabout an axis 147 that is preferably, but not necessarily, orientedbetween the axes of the suture portions 132, 134. In some embodiments,the axis 147 may approximately bisect the angle α defined between theaxes of the suture portions 132, 134.

Rotation of the twister device 140 (or the portion or component of thetwister device 140) can operate to twist, interlace, intertwine, orotherwise secure the suture portions 132, 134 together at a desirablelocation (e.g., within the heart) relative to the tissues T1, T2. Whenthe suture portions 132, 134 are twisted together, they define a pointof intersection 199 of the axes of the suture portions 132, 134. As thesuture portions 132, 134 are further twisted together, the point ofintersection 199 is moved towards the implants 131, 131′ (and thus thetissues T1, T2), the lengths of the suture portions 132, 134 between thepoint of intersection 199 and the respective tissues T1, T2 shorten, thelength of the twisted suture portion 137 proximal to the point ofintersection 199 increases, and the angle α defined between the axes ofthe suture portions 132, 134 increases.

As illustrated in FIG. 1D, a force, F, applied to twisted suture portion137 is carried to the two suture portions, and considering each sutureportion as a pure tension member, an axial force, Fs, carried by eachsuture portion 132, 134 between the twisted portion 137 and the tissuesT1, T2 is carried along the respective axes of suture portion 132, 134.Each axial force, Fs, can be decomposed into a first component, Fa, thatis parallel to the axis of the twisted portion 137 and a secondcomponent, Fb, that is perpendicular to the axis of the twisted portion.The second component, Fb, of the axial force, Fs, in each suture portion132, 134 acts to approximate, or draw together, the tissue T1, T2 towhich the implants 131, 131′ are coupled.

The twister device 140 can be rotated any number of times to further andsuitably approximate the implants 131, 131′ and the tissues T1, T2attached thereto. For example, rotating the twister device 140 causesmore of the suture portion 132 and the suture portion 134 to becomeinterlaced, thereby increasing the length of the twisted suture portion137 and further approximating the implants 131, 131′, as illustratedschematically in FIG. 1C Likewise, the twister device 140 can be rotatedin the opposite direction to shorten the twisted suture portion 137 toreduce the approximation of the implants 131, 131′. Thus, the degree ofapproximation can be increased or decreased until the desired ortargeted approximation is achieved. The twister device 140 can then bewithdrawn from the twisted suture portion 137, and the twisted sutureportion 137 can be secured outside the target region in a suitablelocation (e.g., an outer surface of the heart) with, for example, aproximal anchor 144.

Although the above embodiment describes a method using examples dealingwith a cardiac procedure, the methods and devices described herein arereadily adaptable for various types of tissue repair procedures. Forease of explanation, embodiments described herein are described withrespect to repairing a cardiac mitral valve. It should be understood,however, that the devices and methods described herein can be used torepair other cardiac valves, such as a tricuspid, aortic, or pulmonicvalve, or non-cardiac tissues, such as in orthopedic applications wheretwo or more tissues are to be approximated.

In some embodiments, for example, apparatus and methods are describedherein for remotely securing two or more sutures together within anon-invasive procedure to repair a cardiac valve. In some embodiments,apparatus and methods are described herein for performing a non-invasiveprocedure for repairing a mitral valve using an edge-to-edge stitch(also referred to as an Alfieri procedure) to secure two mitral valveleaflets together.

As illustrated in FIG. 2 , the human heart 10 has four chambers, whichinclude two upper chambers denoted as atria 12, 16 and two lowerchambers denoted as ventricles 14, 18. A septum 20 (see, e.g., FIG. 4 )divides the heart 10 and separates the left atrium 12 and left ventricle14 from the right atrium 16 and right ventricle 18. The heart furthercontains four valves 22, 23, 26, and 27. The valves function to maintainthe pressure and unidirectional flow of blood through the body and toprevent blood from leaking back into a chamber from which it has beenpumped.

Two valves separate the atria 12, 16 from the ventricles 14, 18, denotedas atrioventricular valves. The mitral valve 22, also known as the leftatrioventricular valve, controls the passage of oxygenated blood fromthe left atrium 12 to the left ventricle 14. A second valve, the aorticvalve 23, separates the left ventricle 14 from the aortic artery (aorta)29, which delivers oxygenated blood via the circulation to the entirebody. The aortic valve 23 and mitral valve 22 are part of the leftheart, which controls the flow of oxygen-rich blood from the lungs tothe body. The right atrioventricular valve, the tricuspid valve 24,controls passage of deoxygenated blood into the right ventricle 18. Afourth valve, the pulmonary valve 27, separates the right ventricle 18from the pulmonary artery 25. The right ventricle 18 pumps deoxygenatedblood through the pulmonary artery 25 to the lungs wherein the blood isoxygenated and then delivered to the left atrium 12 via the pulmonaryvein. Accordingly, the tricuspid valve 24 and pulmonic valve 27 are partof the right heart, which control the flow of oxygen-depleted blood fromthe body to the lungs.

Both the left and right ventricles 14, 18 constitute pumping chambers.The aortic valve 23 and pulmonic valve 27 lie between a pumping chamber(ventricle) and a major artery and control the flow of blood out of theventricles and into the circulation. The aortic valve 23 and pulmonicvalve 27 have three cusps, or leaflets, that open and close and therebyfunction to prevent blood from leaking back into the ventricles afterbeing ejected into the lungs or aorta 29 for circulation.

Both the left and right atria 12, 16 are receiving chambers. The mitralvalve 22 and tricuspid valve 24, therefore, lie between a receivingchamber (atrium) and a ventricle to control the flow of blood from theatria to the ventricles and prevent blood from leaking back into theatrium during ejection from the ventricle. Both the mitral valve 22 andtricuspid valve 24 include two or more cusps, or leaflets (not shown inFIG. 2 ), that are encircled by a variably dense fibrous ring of tissuesknown as the annulus (not shown in FIG. 2 ). The valves are anchored tothe walls of the ventricles by chordae tendineae (chordae) 17. Thechordae tendineae 17 are cord-like tendons that connect the papillarymuscles 19 to the leaflets (not shown in FIG. 2 ) of the mitral valve 22and tricuspid valve 24 of the heart 10. The papillary muscles 19 arelocated at the base of the chordae tendineae 17 and are within the wallsof the ventricles. The papillary muscles 19 do not open or close thevalves of the heart, which close passively in response to pressuregradients; rather, the papillary muscles 19 brace the valves against thehigh pressure needed to circulate the blood throughout the body.Together, the papillary muscles 19 and the chordae tendineae 17 areknown as the sub-valvular apparatus. The function of the sub-valvularapparatus is to keep the valves from prolapsing into the atria when theyclose.

The mitral valve 22 is illustrated in FIG. 3A. The mitral valve 22includes two leaflets, the anterior leaflet 52 and the posterior leaflet54, and a diaphanous incomplete ring around the valve, called theannulus 53. The mitral valve 22 has two papillary muscles 19, theanteromedial and the posterolateral papillary muscles (see, e.g., FIG. 2), which attach the leaflets 52, 54 to the walls of the left ventricle14 via the chordae tendineae 17 (see, e.g., FIG. 2 ).

FIG. 3B illustrates a prolapsed mitral valve 22. As can be seen withreference to FIGS. 3B-3D, prolapse occurs when a prolapsed segment of aleaflet 52, 54 of the mitral valve 22 is displaced above the plane ofthe mitral annulus into the left atrium 12 (see FIGS. 3C and 3D)preventing the leaflets from properly sealing together to form thenatural plane or line of coaptation between the valve leaflets duringsystole. Because one or more of the leaflets 52, 54 malfunctions, themitral valve 22 does not close properly, and, therefore, the leaflets52, 54 fail to coapt. This failure to coapt causes a gap 55 between theleaflets 52, 54 that allows blood to flow back into the left atrium,during systole, while it is being ejected by the left ventricle. As setforth above, there are several different ways a leaflet may malfunction,which can thereby lead to regurgitation.

Mitral valve regurgitation increases the workload on the heart and maylead to very serious conditions if left un-treated, such as decreasedventricular function, pulmonary hypertension, congestive heart failure,permanent heart damage, cardiac arrest, and ultimately death. Since theleft heart is primarily responsible for circulating the flow of bloodthroughout the body, malfunction of the mitral valve 22 is particularlyproblematic and often life threatening.

As described in detail in the '761 PCT Application and the '170 PCTApplication, methods and devices are provided for performingnon-invasive procedures to repair a cardiac valve, such as a mitralvalve. Such procedures include procedures to repair regurgitation thatoccurs when the leaflets of the mitral valve do not coapt at peakcontraction pressures, resulting in an undesired back flow of blood fromthe ventricle into the atrium. As described in the '761 PCT Applicationand the '170 PCT Application, after the malfunctioning cardiac valve hasbeen assessed and the source of the malfunction verified, a correctiveprocedure can be performed. Various procedures can be performed inaccordance with the methods described therein to effectuate a cardiacvalve repair, which will depend on the specific abnormality and thetissues involved.

After prepping and placing the subject under anesthesia, atransesophageal echocardiogram (TEE) (2D or 3D), a transthoracicechocardiogram (TTE), intracardiac echo (ICE), or cardio-optic directvisualization (e.g., via infrared vision from the tip of a 7.5 Fcatheter) may be performed to assess the heart and its valves.

After a minimally invasive approach is determined to be advisable, oneor more incisions are made proximate to the thoracic cavity to provide asurgical field of access. The total number and length of the incisionsto be made depend on the number and types of the instruments to be usedas well as the procedure(s) to be performed. The incision(s) should bemade in such a manner to be minimally invasive. As referred to herein,the term minimally invasive means in a manner by which an interior organor tissue may be accessed with as little as possible damage being doneto the anatomical structure through which entry is sought. Typically, aminimally invasive procedure is one that involves accessing a bodycavity by a small incision of, for example, approximately 5 cm or lessmade in the skin of the body. The incision may be vertical, horizontal,or slightly curved. If the incision is placed along one or more ribs, itshould follow the outline of the rib. The opening should extend deepenough to allow access to the thoracic cavity between the ribs or underthe sternum and is preferably set close to the rib cage and/ordiaphragm, dependent on the entry point chosen.

In one example method, the heart may be accessed through one or moreopenings made by a small incision(s) in a portion of the body proximalto the thoracic cavity, for example, between one or more of the ribs ofthe rib cage of a patient, proximate to the xyphoid appendage, or viathe abdomen and diaphragm. Access to the thoracic cavity may be soughtto allow the insertion and use of one or more thorascopic instruments,while access to the abdomen may be sought so as to allow the insertionand use of one or more laparoscopic instruments. Insertion of one ormore visualizing instruments may then be followed by transdiaphragmaticaccess to the heart. Additionally, access to the heart may be gained bydirect puncture (e.g., via an appropriately sized needle, for instancean 18-gauge needle) of the heart from the xyphoid region. Accordingly,the one or more incisions should be made in such a manner as to providean appropriate surgical field and access site to the heart in the leastinvasive manner possible. Access may also be achieved using percutaneousmethods further reducing the invasiveness of the procedure. See forinstance, “Full-Spectrum Cardiac Surgery Through a Minimal IncisionMini-Sternotomy (Lower Half) Technique,” Doty et al., Annals of ThoracicSurgery 1998; 65(2): 573-7 and “Transxiphoid Approach Without MedianSternotomy for the Repair of Atrial Septal Defects,” Barbero-Marcial etal., Annals of Thoracic Surgery 1998; 65(3): 771-4, the entiredisclosures of each of which are incorporated herein by reference.

Once a suitable entry point has been established, the surgeon can useone or more sutures to make a series of stiches in one or moreconcentric circles in the myocardium at the desired location to create a“pursestring” closure. The Seldinger technique can be used to access theleft ventricle in the area surrounded by the pursestring suture bypuncturing the myocardium with a small sharp hollow needle (a “trocar”)with a guidewire in the lumen of the trocar. Once the ventricle has beenaccessed, the guidewire can be advanced, and the trocar removed. Avalved-introducer with dilator extending through the lumen of thevalved-introducer can be advanced over the guidewire to gain access tothe left ventricle. The guidewire and dilator can be removed and thevalved-introducer will maintain hemostasis, with or without a suitabledelivery device inserted therein, throughout the procedure.Alternatively, the surgeon can make a small incision in the myocardiumand insert the valved-introducer into the heart via the incision. Oncethe valved-introducer is properly placed the pursestring suture istightened to reduce bleeding around the shaft of the valved-introducer.

A suitable device, such as a delivery device described in the '761 PCTApplication and/or the '170 PCT Application, may be advanced into thebody and through the valved-introducer in a manner to access the leftventricle. The advancement of the device may be performed in conjunctionwith sonography or direct visualization (e.g., direct transbloodvisualization). For example, the delivery device may be advanced inconjunction with TEE guidance or ICE to facilitate and direct themovement and proper positioning of the device for contacting theappropriate apical region of the heart. Typical procedures for use ofecho guidance are set forth in Suematsu.

As shown in FIG. 4 , one or more chambers, e.g., the left atrium 12,left ventricle 14, right atrium 16, or right ventricle 18 in the heart10 may be accessed in accordance with the methods disclosed herein.Access into a chamber 12, 14, 16, 18 in the heart 10 may be made at anysuitable site of entry but is preferably made in the apex region of theheart, for example, slightly above the apex 26 at the level of thepapillary muscles 19 (see also FIG. 3C). Typically, access into the leftventricle 14, for instance, to perform a mitral valve repair, is gainedthrough the process described above performed in the apical region,close to (or slightly skewed toward the left of) the median axis 28 ofthe heart 10. Typically, access into the right ventricle 18, forinstance, to perform a tricuspid valve repair, is gained through theprocess described above performed in the apical region, close to orslightly skewed toward the right of the median axis 28 of the heart 10.Generally, an apex region of the heart is a bottom region of the heartthat is within the left or right ventricular region and is below themitral valve 22 and tricuspid valve 24 and toward the tip or apex 26 ofthe heart 10. More specifically, an apex region AR of the heart (see,e.g., FIG. 4 ) is within a few centimeters to the right or to the leftof the septum 20 of the heart 10 at or near the level of the papillarymuscles 19. Accordingly, the ventricle can be accessed directly via theapex 26, or via an off-apex location that is in the apical or apexregion AR, but slightly removed from the apex 26, such as via a lateralventricular wall, a region between the apex 26 and the base of apapillary muscle 19, or even directly at the base of a papillary muscle19 or above. Typically, the incision made to access the appropriateventricle of the heart is no longer than about, for example, about 0.5cm. Alternatively, access can be obtained using the Seldinger techniquedescribed above.

The mitral valve 22 and tricuspid valve 24 can be divided into threeparts: an annulus (see 53 in FIGS. 3A and 3B), leaflets (see 52, 54 inFIGS. 3A and 3B), and a sub-valvular apparatus. The sub-valvularapparatus includes the papillary muscles 19 (see FIG. 2 ) and thechordae tendineae 17 (see FIG. 2 ), which can elongate and/or rupture.If the valve is functioning properly, when closed, the free margins oredges of the leaflets come together and form a tight junction, the arcof which, in the mitral valve, is known as the line, plane or area ofcoaptation. Normal mitral and tricuspid valves open when the ventriclesrelax allowing blood from the atrium to fill the decompressed ventricle.When the ventricle contracts, chordae tendineae properly position thevalve leaflets such that the increase in pressure within the ventriclecauses the valve to close, thereby preventing blood from leaking intothe atrium and assuring that all of the blood leaving the ventricle isejected through the aortic valve (not shown) and pulmonic valve (notshown) into the arteries of the body. Accordingly, proper function ofthe valves depends on a complex interplay between the annulus, leaflets,and sub-valvular apparatus. Lesions in any of these components can causethe valve to dysfunction and thereby lead to valve regurgitation. As setforth herein, regurgitation occurs when the leaflets do not coaptproperly at peak contraction pressures. As a result, an undesired backflow of blood from the ventricle into the atrium occurs.

Although the procedures described herein are with reference to repairinga cardiac mitral valve or tricuspid valve by the implantation of one ormore artificial chordae, the methods presented are readily adaptable forvarious types of tissue, leaflet, and annular repair procedures. Themethods described herein, for example, can be performed to selectivelyapproximate two or more portions of tissue to limit a gap between theportions. In general, the methods herein are described with reference toa mitral valve 22 but should not be understood to be limited toprocedures involving the mitral valve.

Example Methods for Approximating Tissues

FIG. 5 illustrates an example method 500 for twisting sutures togetherto approximate distal anchor implants attached to tissue. The method 500can be used with any of the twister devices disclosed herein. The method500 can be used to approximate any tissue that can receive an anchorimplant (e.g., a bulky knot implant) with a suture attached thereto.Examples provided herein focus on implanting artificial tendineae, butother procedures may utilize the method 500. Where the term anchor isused herein, it is to be understood that an anchor refers to anysuitable component or element that serves to anchor a suture to tissuesuch as, for example and without limitation, hooks, barbs, knots (e.g.,bulky knots), and the like.

In some embodiments, the method 500 improves upon existing Alfieriprocedures by twisting sutures to adjust the tension and direction offorce vectors applied to tissues to be approximated. Advantageously, themethod 500 allows an operator (e.g., a physician or surgeon) a way tochange force vectors applied by anchor implants in tissue. For example,when implanting artificial tendineae, the knot that coalesces aplurality of the sutures or cords can be adjusted to be at any locationfrom the apex of the heart to the valve with the implanted cords. Thiscan be used to adjust both the angle of the force vectors as well as themagnitude of the force vectors, providing increased control to theoperator.

At step 505, two or more artificial cords are attached to targetedtissue. The artificial cords include anchor implants at a distal endthat are anchored to the targeted tissue, e.g., a posterior or anteriorleaflet. The cords also include sutures extending proximally from theanchor implants. These sutures extend proximally from the implants to aregion away and/or outside of the targeted region. In some embodiments,the targeted region is within the heart or within a chamber of the heart(e.g., the left ventricle).

At step 510, the proximal ends or portions of the sutures are secured toa twister device. The sutures can be secured to any portion of thetwister device. In some embodiments, the sutures are releasably securedto the twister device to allow for removal of the twister device afterapproximation of the targeted tissue. In various embodiments, thetwister device or the portion of the twister device to which the suturesare attached can be used as a pledget or other anchoring mechanism thatis used to anchor the sutures after approximation of the targetedtissue. In such embodiments, the portion of the twister device to whichthe sutures are anchored is releasable from the main body of the twisterdevice.

At step 515, the twister device is twisted to intertwine the suturessecured to the twister device. In some embodiments, the entire twisterdevice is twisted to intertwine the sutures. In certain embodiments, aportion of the twister device is rotated to cause the portion of thetwister device to which the sutures are secured to rotate, therebycausing the sutures to intertwine.

Twisting the twister device to intertwine or interlace the suturescauses the implants (and the tissues) to approximate. By increasing thenumber of twists, the targeted tissue can be approximated. Similarly, bydecreasing the number of twists, the approximation of the tissues can bedecreased. Thus, twisting the twister device allows an operator tocontrol approximation of the twister devices.

In addition, twisting the twister device to intertwine or interlace thesutures causes a point of intersection of the sutures to move closer tothe targeted tissues. This adjusts the angles of the forces applied tothe implants, and therefore to the tissue. In addition, the portion ofthe sutures that are twisted together can increase in strength relativeto individual sutures. This can advantageously result in stronger ormore durable artificial tendineae, for example.

At optional step 517, the tension of the sutures can be adjusted. Thiscan be done, for example, by pulling proximally on the intertwinedsutures. This can be done in conjunction with the twisting of thetwister device to tailor the force vectors on the implants to achievetargeted tissue approximation. For example, twisting (or untwisting) canbe done simultaneously with pulling (or releasing tension) on thesutures to achieve targeted force vectors or targeted tissueapproximation.

At step 520, imaging or other methods are used to verify that thetargeted approximation of the tissues has been achieved. This feedbackstep allows the operator to iteratively adjust the number of twistsapplied to the sutures and/or the amount of tension on the sutures(e.g., as provided in optional step 517). The iterative nature of thisportion of the method 500 is illustrated using an arrow that goes fromstep 520 back to step 515. Imaging methods include cardiac ultrasoundand echo guidance, as described herein.

Once the targeted approximation of the targeted tissue has beenachieved, the intertwined sutures are anchored at step 525. Theanchoring step is done to prevent or to reduce the likelihood that theintertwined sutures will unwind. The sutures can be anchored to a tissuewall, such as an external wall of the heart. A pledget can be used asthe anchor. For example, PTFE (Teflon®, Dupont, Wilmington, Del.) feltcan be used as an anchor where the felt is attached to the tissue wallto prevent rotation of the sutures. In some embodiments, the anchorincludes a plurality of holes through which the sutures extend so thatthe sutures do not unwind. Knots can be used to anchor the sutures toprevent unwinding.

In some embodiments, the sutures can be released from the anchor toallow further twisting and/or tensioning in a separate, later procedure.A new twister device or the previous twister device can be used to twistand/or tension the unanchored sutures. The sutures can then bere-anchored after the force vectors have been adjusted.

Advantageously, the twisting portion of the method 500 can be performedoutside of the target region. This can allow greater accessibility andflexibility to operators performing the procedure. Another advantage ofthe method 500 is that it is adjustable and reversible. Because themethod 500 does not require employing a clamping feature, the procedureallows for titration before anchoring of the sutures. The method 500also allows for real-time adjustment of tissue approximation to achievecoaptation between leaflets because an operator can adjust the tensionof the sutures, and by extension the approximation of the implants andtargeted tissue, based on feedback from a visualization system (e.g.,cardiac ultrasound).

The method 500 also provides other advantages over other approaches toaddressing MR. For example, implanting a clip in the mitral valve toaddress MR does not provide adjustability. In contrast, the method 500allows for real-time adjustability. Furthermore, the method 500 can beaccomplished using real-time imaging or other feedback to reduce oreliminate MR. This allows an operator to see the effects of theprocedure in real time allowing for the operator to make adjustments toachieve targeted results. In addition, if reoperation is required thevalve is unaffected by the method 500 whereas a mitral valve clip maydestroy or damage the tissue. Furthermore, a mitral valve clip is arelatively large amount of hardware to implant in the heart which mayincrease the risk of embolism and tissue rejection. With the method 500,the only materials implanted in the body are the sutures which present asignificantly lower risk to the patient.

Example Devices for Approximating Tissues

FIGS. 6A, 6B, 6C, and 6D illustrate block diagrams of example twisterdevices that can be used to perform the example method of FIG. 5 . It isto be understood, however, that the method 500 can be performed with anysuitable device or apparatus. The twister devices described herein aremerely examples of devices capable of performing the method 500.

FIG. 6A illustrates an example twister device 640 a that includes atwisting component 641 a and a suture management component 648 a. Thetwisting component 641 a is configured to cause the suture managementcomponent 648 a to rotate. Thus, when suture end portions 632, 634 areattached to the suture management component 648 a, the sutures becomeintertwined or interlaced, as described herein. In some embodiments, thetwisting component 641 a causes the entire twister device 640 a torotate or twist. In some embodiments, the twisting component 641 acauses the suture management component 648 a to rotate while othercomponents of the twister device 640 a remain stationary or do notrotate.

The twisting component 641 a can be any suitable mechanical element thatcan cause the suture management component 648 a to rotate about an axis.In some embodiments, the twisting component 641 a is manually actuatedby an operator (e.g., a handle that is twisted). In certain embodiments,the twisting component 641 a is automatically engaged or operated (e.g.,similar to a drill being operated using a button or trigger). In someembodiments, the twisting component 641 a is integrally formed with thesuture management component 648 a so that rotation of the twistingcomponent 641 a causes rotation of the suture management component 648a. In some embodiments, the suture management component 648 a isconfigured to rotate relative to the twisting component 641 a whereinthe rotation of the suture management component 648 a is controlled bythe twisting component 641 a. The twisting component 641 a can be anergonomic fitting designed for manual manipulation by an operator.

The suture management component 648 a can include one or more featuresto which suture end portions can be attached. As described herein, thesuture management component 648 a can include one or more featuresaround which the suture end portions can be wrapped to releasably securethe suture end portions to the suture management component 648 a. Thesuture management component 648 a can include one or more such featuresto allow different suture end portions to be secured to differentfeatures of the suture management component 648 a. In some embodiments,the suture management component 648 a includes locking features that areconfigured to lock the suture end portions to the suture managementcomponent 648 a. The purpose of the suture management component 648 a isto secure the suture end portions while the twister device 640 a istwisted so that the sutures become intertwined.

In some embodiments, the suture end portions 632, 634 can be attached toa distal end 645 of the twister device 640 a with the twisting component641 a being at a proximal end 646 of the twister device 640 a.

FIG. 6B illustrates another example twister device 640 b that is similarto the twister device 640 a of FIG. 6A. However, the twister device 640b forms an interior lumen 642 that passes from the distal end 645 to theproximal end 646 of the twister device 640 b. The lumen 642 allows thesuture end portions 632, 634 to pass through the twister device 640 b tobe secured to the suture management component 648 b (which is similar indesign and function to the suture management component 648 a of FIG.6A). The lumen 642 is configured to allow two or more sutures to passthrough to the suture management component 648 b. As with the twisterdevice 640 a of FIG. 6A, the twisting component 641 b causes the suturemanagement component 648 b to rotate to intertwine the sutures. This canbe accomplished in any suitable fashion, as described with reference toFIG. 6A and elsewhere herein.

FIG. 6C illustrates another example twister device 640 c that includes avalve 643 (e.g., a duckbill valve) to limit and/or to preventundesirable backflow of blood or other bodily fluids. In all otheraspects, the twister device 640 c is similar to the twister device 640 bof FIG. 6B.

FIG. 6D illustrates another example twister device 640 d that includesan access port 647 configured to receive, for example, a heparinizedsaline solution to limit and/or to prevent undesirable clotting duringthe procedure. In all other aspects, the twister device 640 d is similarto the twister device 640 b of FIG. 6B.

Additional Example Methods and Twister Devices

FIGS. 7, 8A, and 8B illustrate an example method and an example devicefor securing an artificial tendineae that has been implanted asdescribed in the '761 PCT Application and/or the '170 PCT Application.FIG. 7 illustrates schematically a mitral valve 222 with leaflets 252,254 that are separated by a gap 263. Two anchor implants (e.g., bulkyknot implants) 231, 231′ are disposed on an atrial, distal, or top sideof the leaflets 252, 254, respectively. The implants 231, 231′ can beformed with a suture material that forms a loop on the atrial side ofthe leaflets 252, 254 and extends through the leaflets 252, 254, withtwo loose suture end portions that extend on the ventricular, proximal,or bottom side of the leaflets 252, 254. The implant 231 has suture endportions 232 and 233, and the implant 231′ has suture end portions 234and 235 (not shown in FIG. 7 ).

After the implants 231, 231′ are in a desired or targeted position(which can be confirmed with imaging, for example), a twister device 240as illustrated in FIGS. 8A (perspective view) and 8B (side view withsuture end portions routed therethrough) can be used during a procedureto secure the implants 231, 231′ in the desired position and to securethe valve leaflets 252, 254 in an edge-to-edge relationship. Further, inaddition to or instead of creating the edge-to-edge relationship, topromote a larger surface of coaptation, using the twister device 240,the implants 231, 231′ can be secured together to pull or to otherwisemove the posterior annulus towards the anterior leaflet and/or theanterior annulus towards the posterior leaflet to reduce the distancebetween the anterior annulus and the posterior annulus, e.g., theseptal-lateral distance, by about 10%-40%. Approximating the anteriorannulus and the posterior annulus in this manner can decrease the valveorifice, and thereby decrease, limit, or otherwise prevent undesirableregurgitation. This technique can be valuable in both degenerative MRwith a prolapsed leaflet where the annulus is dilated and in functionalMR where the leaflet function is normal but the annulus has dilated andthere is a gap between the leaflets that can be closed by approximatingthe tissue.

In this embodiment, as illustrated in FIGS. 8A and 8B, the twisterdevice 240 defines a lumen 242 from its distal end 245 to its proximalend 246, and includes tie knobs 248, 248′ disposed at the proximal end246. As described in more detail below, the suture end portions 232,233, 234, 235 can be passed through the lumen 242 from the distal end245 to the proximal end 246, and then tied-off, wrapped around, fixed,or otherwise secured to the tie knobs 248, 248′. If one or more of theleaflets is prolapsed, the artificial cord(s) attached to the prolapsedleaflet(s) can be tensioned before being tied-off around the knobs.Similarly stated, the tie knob 248 can be used to hold a suture portionextending from the implant 231, and the tie knob 248′ can be used tohold a suture portion extending from the implant 231′. With the sutureend portions 232, 233, 234, 235 secured to the respective tie knobs 248,248′, the twister device 240 can be rotated, twisted, or otherwisemanipulated to intertwine the suture end portions 232, 233, 234, 235.Intertwining the suture end portions 232, 233, 234, 235 causes the twoimplants 231, 231′ to approximate, in turn causing the leaflets 252, 254to approximate. This can be done to secure the leaflets 252, 254 in anedge-to-edge relationship, as described in more detail herein. After theleaflets 252, 254 are secured in an edge-to-edge relationship in adesirable manner, the lengths of the suture end portions 232, 233, 234,235 can be further adjusted until the desired length is established. Theproximal end portions of the suture end portions 232, 233, 234, 235 canthen be secured to an outer surface of the heart at, for example, theapex region with a proximal anchor (examples of which are describedherein with reference to FIGS. 1A-1D).

FIGS. 9A-9M illustrate an example method similar to the method describedabove with respect to FIGS. 7, 8A, and 8B using the twister device 240to approximate two model valve leaflets 252, 254 disposed within a modelheart H. The example method illustrated in FIGS. 9A-9M uses avalved-introducer 290 to gain access to the model heart H and to deliverthe implants (not shown) to the model leaflets 252, 254. With implantssecured to the model leaflets 252, 254, and the suture end portions 232,233, 234, 235 extending from the implants through the model heart H andthe valved-introducer 290, extending outside the model heart H, thesuture end portions 232, 233, 234, 235 can be operably coupled to thetwister device 240.

To operably couple the suture end portions 232, 233, 234, 235 to thetwister device 240, a snare or threader 280 can be used to thread thesuture end portions 232, 233, 234, 235 through the lumen 242 of thetwister device 240. As illustrated in FIG. 9B, the threader 280 can beinserted through the lumen 242 of the twister device 240. The threader280 defines a terminal end 282 (see, e.g., FIG. 9B) configured to becoupled to the suture end portions 232, 233, 234, 235, as illustrated inFIG. 9A. With the suture end portions 232, 233, 234, 235 extendingoutside the model heart H from the valved-introducer 290 and coupled tothe terminal end 282 of the threader 280, the suture end portions 232,233, 234, 235 can be threaded through the lumen 242 of the twisterdevice 240 from its distal end 245 to its proximal end 246, asillustrated in FIG. 9C. The distal end 245 of the twister device 240 canthen be inserted into the valved-introducer 290, as illustrated in FIG.9D. With the distal end 245 of the twister device 240 inserted into thevalved-introducer 290, the suture end portions 232, 233, 234, 235 can bepulled proximally and a vascular cap or boot 249 can be used to plug thelumen 242 of the twister device 240 at its proximal end 246, asillustrated in FIGS. 9E-9G. The cap 249 can be used to limit and/or toprevent an undesirable backflow of blood. Alternatively, a valve (e.g.,a hemostatic valve) can be positioned within the lumen 242 of thetwister device 240 to reduce, minimize, or eliminate blood loss,examples of which are described herein. As illustrated in FIG. 9H, thesuture end portions 232, 233, 234, 235 can then be secured to thetwister device 240 by, for example, wrapping the suture end portions232, 233, 234, 235 around the tie knobs 248, 248′.

With the suture end portions 232, 233, 234, 235 fixedly coupled to thetwister device 240, the twister device 240 can be rotated to twist,intertwine, and/or interlace a portion 236 of the suture end portions232, 233, 234, 235 within the model heart H to approximate the implantsand, consequently, the valve leaflets 252, 254 to which the implants areanchored, as illustrated in FIGS. 91 and 9J. Controlling the number ofturns or twists of the twister device 240 allows the user to preciselyapproximate the valve leaflets 252, 254. Control of the approximationcan be aided using, for example, echo guidance, which can be used todetermine in real time with a beating heart a targeted reduction orelimination of mitral valve regurgitation. The twisting can be performedby hand or using an automated device to rotate the twister device 240.The appropriate amount of twisting can be determined visually using echoguidance, by determining an appropriate number of twists, by measuringthe force required to rotate the twister device 240, or any othersuitable method. Once the desired or targeted result (e.g., a suitablereduction in mitral valve regurgitation) is achieved (e.g., confirmed byremote visualization), the suture end portions 232, 233, 234, 235 can bereleased from the tie knobs 248, 248′ of the twister device 240. Thenthe valved-introducer 290 and the twister device 240 can be slidablywithdrawn along the suture end portion 232, 233, 234, 235, leaving thesuture end portions 232, 233, 234, 235 extending from the model heart Hthrough which the valved-introducer 290 was previously disposed, asillustrated in FIG. 9K.

To prevent undesirable unwinding of the intertwined suture pairs duringremoval of the valved-introducer 290 and the twister device 240, a clamp292 can be used to clamp suture end portions 232, 233, 234, 235, asillustrated in FIG. 9L. The suture end portions 232, 233, 234, 235 canthen be anchored outside the apex of the ventricle by tying knots, usinga pledget, or any other suitable anchoring mechanism, as illustrated inFIG. 9M.

FIGS. 10A-10J illustrate an example method and an example device forsecuring artificial tendineae that has been implanted as described inthe '761 PCT Application and/or the '170 PCT Application. Similar to themethod and device described with respect to FIG. 7 , two implants 331,331′ can be delivered and disposed on an atrial, distal, or top side ofleaflets 352, 254, respectively. The implants 331, 331′ can be formedwith a suture material that forms a loop on the atrial side of theleaflets 352, 354 and extends through the leaflets 352, 354, with twoloose suture end portions that extend on the ventricular, proximal, orbottom side of the leaflets 352, 354. The implant 331 has suture endportions 332 and 333, and the implant 331′ has suture end portions 334and 335. In some embodiments, implants can be formed separate from thesuture end portions and then attached thereto. In this manner, theimplants can be attached to the suture material, deployed on the atrialside of the leaflets, and the suture end portions can extend from theimplants and through the leaflets to the ventricular side of theleaflets, and then anchored outside the heart H as described in furtherdetail herein.

After the implants 331, 331′ are in a desired or targeted position(which can be confirmed using imaging, for example), a twister device340 as illustrated in FIGS. 10A and 10B can be used during a procedureto secure the implants 331, 331′ in the desired position and to securethe valve leaflets 352, 354 in an edge-to-edge relationship. Forexample, using the twister device 340, the implants 331, 331′ can besecured together to decrease the septal-lateral distance of the mitralvalve annulus.

As illustrated in FIGS. 10A and 10B, the twister device 340 defines alumen 342 from its distal end 345 to its proximal end 346. The twisterdevice 340 includes tie knobs 348, 348′ disposed at the proximal end346. The twister device 340 further includes suture locks 349, 349′configured to releasably engage with the tie knobs 348, 348′,respectively, to secure the suture end portions 332, 333, 334, 335 tothe tie knobs 348, 348′. Although not shown, the twister device 340further includes a valve (e.g., a duckbill valve) configured to limitand/or to prevent undesirably backflow of blood or other bodily fluids.In some instances, the twister device 340 can further include an accessport configured to receive, for example, a heparinized saline to limitand/or prevent undesirable clotting during the procedure.

As described in more detail herein, the suture end portions 332, 333,334, 335 can be passed through the lumen 342 from the distal end 345 tothe proximal end 346, and then tied-off, wrapped around, fixed, orotherwise secured to the tie knobs 348, 348′. In some embodiments, thetie knob 348 can be used to hold a suture portion extending from theimplant 331, and the tie knob 348′ can be used to hold a suture portionextending from the implant 331′. With the suture end portions 332, 333,334, 335 secured to the respective tie knobs 348, 348′, and the suturelocks 349, 349′ disposed in an engaged position with the tie knobs 348,348′, respectively, the twister device 340 can be rotated, twisted, orotherwise manipulated to approximate the two implants 331, 331′ and inturn the leaflets 352, 354, to secure the leaflets 352, 354 in theedge-to-edge relationship, as described in more detail herein. After theleaflets 352, 354 are secured in an edge-to-edge relationship in adesirable manner, the lengths of the suture end portions 332, 333, 334,335 can be adjusted until the desired length is established. Theproximal end portions of the suture end portions 332, 333, 334, 335 canthen be secured to an outer surface of the heart H at, for example, theapex region, Ap, with a proximal anchor.

FIGS. 10C-10J illustrate a method using the twister device 340 toapproximate two model valve leaflets 352, 354 disposed within a modelheart H. As illustrated in FIG. 10C using the model heart H, avalved-introducer 390 is used to gain access to the model heart H and todeliver the implants 331, 331′ (illustrated in FIG. 10K) to the modelleaflets 352, 354. With the implants 331, 331′ secured to the modelleaflets 352, 355, and the suture end portions 332, 333, 334, 335extending from the implants 331, 331′ through the model heart and thevalved-introducer 390, and outside the model heart H, the suture endportions 332, 333, 334, 335 can be operably coupled to the twisterdevice 340.

To operably couple the suture end portions 332, 333, 334, 335 to thetwister device 340, a threader or snare 380 can be used to thread thesuture end portions 332, 333, 334, 335 through the lumen 342 of thetwister device 340. The threader 380 can be inserted through the lumen342 of the twister device 340. The threader 380 defines a terminal end382 configured to be coupled to the suture end portions 332, 333, 334,335. With the suture end portions 332, 333, 334, 335 extending outsidethe model heart H from the valved-introducer 390 and coupled to theterminal end 382 of the threader 380, the suture end portions 332, 333,334, 335 can be threaded through the lumen 342 of the twister 380 fromits distal end 345 to its proximal end 346, as illustrated in FIG. 10D.As illustrated in FIG. 10E, the suture end portions 332, 333, 334, 335can then be secured to the twister device 340 by, for example, wrappingthe suture end portions 332, 333, 334, 335 around the tie knobs 348,348′. With the suture end portions 332, 333, 334, 335 coupled to the tieknobs 348, 348′, the suture locks 349, 349′ can be moved to theirrespective locked positions, as illustrated in FIG. 10F, in which eachsuture lock 349, 349′ engages with a respective tie knob 348, 348′ tosecure the suture end portions 332, 333, 334, 335 to the tie knobs 348,348′. The distal end 345 of the twister device 340 can then be insertedinto the valved-introducer 390, as illustrated in FIG. 10F.

With the suture end portions 332, 333, 334, 335 fixedly coupled to thetwister device 340, the twister device 340 is rotated to twist,intertwine, and/or interlace a portion of the suture end portions 332,333, 334, 335 within the model heart H to approximate the implants 331,331′ and the valve leaflets 352, 354 to which the implants 331, 331′ areanchored, as illustrated in FIG. 10G with respect to the model heart H,and as further illustrated in FIG. 10K with respect to a cross-sectionof a representation of a human heart.

Controlling the number of turns or twists of the twister device 340allows the user to precisely approximate the valve leaflets 352, 354.Control of the approximation can be aided using, for example, echoguidance, which can be used to determine in real time with a beatingheart a targeted reduction or elimination of mitral valve regurgitation.Once the desired result (e.g., a suitable reduction in mitral valveregurgitation) is achieved (e.g., confirmed by remote visualization),the suture end portions 332, 333, 334, 335 can be released from the tieknobs 348, 348′ of the twister device 340. Then the twister device 340can be removed by slidably withdrawing it along the suture end portions332, 333, 334, 335 to leave the suture end portions 332, 333, 334, 335extending proximally from the valved-introducer 390, as illustrated inFIG. 10H. With the twister device 340 removed from the valved-introducer390, a first clamp 394 is used to clamp the suture end portions 332,333, 334, 335 such that slidable movement of the suture end portions332, 333, 334, 335 relative to the valved-introducer 390 is limitedand/or prevented, as illustrated in FIG. 10H. With the first clamp 394engaged with the suture end portions 332, 333, 334, 335, the suture endportions 332, 333, 334, 335 can be selectively tensioned (e.g., pulledproximally while monitoring the valve leaflets 353, 354 and anyassociated regurgitation). After confirming the desirable or targetedtension, a second clamp 392 can then be used to clamp the suture endportions 332, 333, 334, 335, the first clamp 394 can be removed, andknots can be tied using the suture end portions 332, 333, 334, 335 toprevent the twisted sutures from unraveling, as illustrated in FIGS. 10Iand 10J. With one or two knots in place to prevent the rotations fromuntwisting, the second clamp 392 can be removed and thevalved-introducer 390 can be removed. The suture end portions 332, 333,334, 335 can then be anchored outside the apex of the ventricle usingthe knots, a pledget, or any other suitable anchoring mechanism. In someinstances, for example, 16 knots (or 8 square knots) can be used toprevent such undesirable unraveling.

Although in this embodiment the method includes withdrawing the twisterdevice 340 from the valved-introducer 390, and clamping the suture endportions 332, 333, 334, 335 at the proximal end of the valved-introducer390, in some implementations, once suitable reduction in mitral valveregurgitation is achieved (e.g., confirmed by remote visualization suchas echo guidance) and the suture end portions 332, 333, 334, 335 arereleased from the tie knobs 348, 348′ of the twister device 340, boththe twister device 340 and the valved-introducer 390 can be slidablywithdrawn proximally along the suture end portions 332, 333, 334, 335.In such implementations, the first clamp 394 can be used to clamp thesuture end portions 332, 333, 334, 335 near the heart (e.g., between theventricle and the distal end of the valved-introducer 390).

FIGS. 11A-11O illustrate an example method and an example device forsecuring an artificial tendineae that has been implanted as described inthe '761 PCT Application and/or the '170 PCT Application. Similar toprevious embodiments described herein, two implants can be delivered anddisposed on an atrial, distal, or top side of leaflets 452, 454,respectively. The implants can be formed with a suture material thatforms a loop on the atrial side of the leaflets 452, 454 and extendsthrough the leaflets 452, 454, with two loose suture end portions thatextend on the ventricular, proximal, or bottom side of the leaflets 452,454. A first implant has suture end portions 432 and 433, and a secondimplant has suture end portions 434 and 435. In some embodiments,implants can be formed separate from the suture end portions and thenattached thereto. In this manner, the implants can be attached to thesuture material, deployed on the atrial side of the leaflets, and thesuture end portions can extend from the implants and through theleaflets to the ventricular side of the leaflets, and then anchoredoutside the heart H as described in further detail herein.

After the implants are in a desired or targeted position (which can beconfirmed using imaging, for example), a twister device 440 asillustrated in FIG. 11A can be used during a procedure to secure theimplants in the desired or targeted position and to secure the valveleaflets 452, 454 in an edge-to-edge relationship. Further, in additionto or instead of creating the edge-to-edge relationship, to promote alarger surface of coaptation, using the twister device 440, the implantscan be secured together to pull or otherwise move the posterior annulustowards the anterior leaflet and/or the anterior annulus towards toposterior leaflet, thereby reducing the distance between the anteriorannulus and the posterior annulus, e.g., the septal-lateral distance, byabout 10%-40%. Approximating the anterior annulus and the posteriorannulus in this manner can decrease the valve orifice, and therebydecrease, limit, or otherwise prevent undesirable regurgitation.

The twister device 440 defines a lumen 442 from its distal end 445 toits proximal end 446, and includes tie knobs 448, 448′ (illustrated inthe partial detailed view of FIG. 11C) disposed at the proximal end 446.The twister device 440 further includes a valve (e.g., a duckbill valve)configured to limit and/or prevent undesirably backflow of blood orother bodily fluids. In some instances, the twister device 440 canfurther include an access port configured to receive, for example, aheparinized saline to limit and/or prevent undesirable clotting duringthe procedure. As illustrated in the partial detailed view of FIG. 11B,the distal end 445 of the twister device 440 defines a first hole 459and a second hole 469 both configured to receive the suture end portions432, 433, 434, 435.

As described in more detail herein, the suture end portions 432, 433,434, 435 can be passed through the lumen 442 from the distal end 445 tothe proximal end 446, and then tied-off, wrapped around, fixed, orotherwise secured to the tie knobs 448, 448′. Similarly stated, the tieknob 448 can be used to hold a suture portion extending from a firstimplant, and the tie knob 448′ can be used to hold a suture portionextending from a second implant. With the suture end portions 432, 433,434, 435 secured to the respective tie knobs 448, 448′, the twisterdevice 440 can be rotated, twisted, or otherwise manipulated toapproximate the two implants and in turn the leaflets 452, 454, tosecure the leaflets 452, 454 in the edge-to-edge relationship, asdescribed in more detail herein. After the leaflets 452, 454 are securedin an edge-to-edge relationship in a desirable manner, the lengths ofthe suture end portions 432, 433, 434, 435 can be adjusted until thedesired or targeted length is established. The proximal end portions ofthe suture end portions 432, 433, 434, 435 can then be secured to anouter surface of the heart H at, for example, the apex region, with aproximal anchor.

FIGS. 11D-11O illustrate a method using the twister device 440 toapproximate two model valve leaflets 452, 454 disposed within a modelheart H. As illustrated in FIG. 11I using the model heart H, avalved-introducer 490 is used to gain access to the model heart H anddeliver the implants to the model leaflets 452, 454. With the implantssecured to the model leaflets 452, 454, and the suture end portions 432,433, 434, 435 extending from the implants through the model heart andthe valved-introducer 490, extending outside the model heart H, thesuture end portions 432, 433, 434, 435 can be operably coupled to thetwister device 440.

To operably couple the suture end portions 432, 433, 434, 435 to thetwister device 440, a threader or snare 480 can be used to thread thesuture end portions 432, 433, 434, 435 through the lumen 442 of thetwister device 440. With the suture end portions 432, 433, 434, 435extending outside the model heart H from the valved-introducer 490, thefree ends of the suture end portions 432, 433 are inserted through thefirst hole 459, as illustrated in FIG. 11D, and the free ends of thesuture end portions 434, 435 are inserted through the second hole 469,as illustrated in FIG. 11E. Next, the threader 480 is inserted into thelumen 442 from the proximal end 446 to the distal end 445 such that aloop defined by the threader 480 is lined up with the first hole 459, asillustrated in FIG. 11F. With the threader 480 lined up in this manner,the free ends of the suture end portions 432, 433, 434, 435 are insertedthrough the first hole 459 and through the loop of the threader 480, asillustrated in FIG. 11G. Next, the threader 480 is withdrawn proximallytowards the proximal end 446 of the twister device 440, pulling thesuture end portions 432, 433, 434, 435 therewith until the free ends ofthe suture end portions 432, 433, 434, 435 extend through and out of thelumen 442 at the proximal end 446 of the twister device 440, asillustrated in FIG. 11H. In this manner, the operator can selectivelycontrol twisting of the suture end portions 432, 433, 434, 435 whilelimiting and/or preventing the suture end portions 432, 433, 434, 435from bunching up, e.g., in the valved-introducer 490.

With the suture end portions 432, 433, 434, 435 threaded through thetwister device 440 in this manner, the distal end 445 of the twisterdevice 440 can be inserted into the valved-introducer 490, andpositioned exactly where the operator wants the twisting to start. Thenthe suture end portions 432, 433, 434, 435 can then be secured to thetwister device 440 by, for example, wrapping the suture end portions432, 433, 434, 435 around the tie knobs 448, 448′, as shown in FIG. 11I.With the suture end portions 432, 433, 434, 435 fixedly coupled to thetwister device 440, and the distal end 444 of the twister device 440inserted through the valved-introducer 490 and into the ventricle of themodel heart H, the twister device 440 is rotated to twist, intertwine,and/or interlace a portion of the suture end portions 432, 433, 434, 435within the model heart H to approximate the implants and the valveleaflets 452, 454 to which the implants are anchored, as illustrated inFIGS. 11J and 11K.

In some instances, with the suture end portions 432, 433, 434, 435fixedly coupled to the twister device 440, the operator can rotate thetwister device 440 to twist, intertwine, and/or interlace a portion ofthe suture end portions 432, 433, 434, 435. The suture end portions 432,433, 434, 435 can then be released from the twister device 440 (e.g.,released from the tie knobs 448, 448′), and the twister device 440 canbe slid or otherwise moved proximally along or about the suture endportions 432, 433, 434, 435. The suture end portions 432, 433, 434, 435can then be secured again to the twister device 440 which can be furtherrotated to further twist, intertwine, and/or interlace a portion of thesuture end portions 432, 433, 434, 435. This process can be repeated anysuitable number of times, e.g., until the twister device 440 has beenwithdrawn completely from the valved-introducer 490, leaving asufficient interlaced portion of the suture end portions 432, 433, 434,435. FIG. 11J illustrates the twisted portion 437 of the suture endportions 432, 433, 434, 435 within the model heart H, and FIG. 11Killustrates the valve leaflets 452, 454 in the approximated position.

Controlling the number of turns or twists of the twister device 440allows the user to precisely approximate the valve leaflets 452, 454.Control of the approximation can be aided using, for example, echoguidance, which can be used to determine in real time with a beatingheart a targeted reduction or elimination of mitral valve regurgitation.Once the desired or targeted result (e.g., a suitable reduction inmitral valve regurgitation) is achieved (e.g., confirmed by remotevisualization), the suture end portions 432, 433, 434, 435 can bereleased from the tie knobs 448, 448′ of the twister device 440. Thenthe twister device 440 and the valved-introducer 490 can be slidablywithdrawn along the suture end portions 432, 433, 434, 435. Once aportion of the suture end portions 432, 433, 444, 445 disposed betweenthe outer surface of the heart and the distal end of one or both of thevalved-introducer 490 and/or the twister device 440 are exposed to theoperator, as illustrated in FIG. 11L, a first clamp 494 can be used toclamp the suture end portions 432, 433, 434, 435 such that both slidablemovement of the suture end portions 432, 433, 434, 435 relative to thevalved-introducer 490 and unwinding of the interlaced portion is limitedand/or prevented, as illustrated in FIG. 11M.

With the first clamp 494 engaged with the suture end portions 432, 433,434, 435, the suture end portions 432, 433, 434, 435 can be selectivelytensioned (e.g., pulled proximally while monitoring the valve leaflets452, 454 and any associated regurgitation). After confirming thedesirable tension, a second clamp 492 can then be used to clamp thesuture end portions 432, 433, 434, 435 near or adjacent to the outsidesurface of the heart, as illustrated in FIG. 11N, the first clamp 494can be removed, and knots can be tied using the suture end portions 432,433, 434, 435 to prevent the twisted sutures from unraveling, asillustrated in FIG. 11O. In some instances, for example, 16 knots (or 8square knots) can be used to prevent such undesirable unraveling. Thesuture end portions 432, 433, 434, 435 can then be anchored outside theapex of the ventricle using the knots, a pledget, or any other suitableanchoring mechanism.

While in various embodiments described herein, methods have includedremoving a twister device from the cords or sutures after the cords wereinterlaced, it should be understood that for any of these embodiments,the process of interlacing the cords is adjustable (includingreversible) in real-time. In this manner, if an operator applies toomany twists (e.g., identified as such under remote visualization), theoperator can simply rotate or twist the twister device in an oppositedirection to partially or fully unlace or unravel the cords. Theoperator could then optionally begin interlacing the cords again untilthe suitable number of twists is achieved.

FIGS. 12A and 12B illustrate another example twister device 1240 with arotating spin lock 1248. The rotating spin lock 1248 can be used tosecure suture end portions 1232, 1233, 1234, 1235 to the twister device1240 so that upon rotation of the twisting component 1241, the suturesintertwine. The rotating spin lock 1248 can be beneficial for hemostasisand suture management. The rotating spin lock 1248 is an adjustable leakproof seal configured to grip the suture end portions 1232, 1233, 1234,1235 and to prevent backflow of blood during the procedure.

The rotating spin lock 1248 allows for unimpeded threading of the sutureend portions 1232, 1233, 1234, 1235 in an open position. Once the sutureend portions 1232, 1233, 1234, 1235 are pulled through, the rotatingspin lock 1248 is partially closed to reduce the gap sufficient for thesuture end portions 1232, 1233, 1234, 1235 to be adjusted and pulledthrough simultaneously as the tubular end 1245 of the twister device1240 is inserted into the introducer 1290. This can result in minimalblood reflux.

Once the twister device 1240 is fully inserted in the valve introducer1290, the rotating spin lock 1248 is rotated to a fully closed position.The rotating spin lock 1248 includes a valve that clamps down on thesuture end portions 1232, 1233, 1234, 1235 with a firm grip to preventthe suture end portions 1232, 1233, 1234, 1235 from slipping andtangling as the twisting component 1241 is rotated. In some embodiments,a side port can be added to the rotating spin lock 1248 to allow forcontinuous pressurized flow of heparinized saline to reduce or toprevent blood from clotting and to reduce or prevent aspiration of airinto the system.

Repairing a cardiac valve (e.g., a mitral valve) by implanting a distalanchor or implant, as described herein, is often influenced by apatient's particular anatomy. When the combined length of the posteriorleaflet and the anterior leaflet is significantly larger than the A-Pdimension of the mitral valve, the likelihood of a successful repair issignificantly higher. For example, a patient having a large posteriorleaflet is desirable, as a large posterior leaflet provides a largesurface of coaptation with the anterior leaflet, thereby providing asufficient seal when the leaflets coapt, e.g., to limit regurgitation.Conversely, a patient having a small posterior leaflet will have arelatively smaller surface of coaptation. Similarly, a patient having alarge anterior leaflet can help lead to a desirable and successfulrepair. Ultimately, the effectiveness and durability of a repair of thisnature is influenced greatly by the amount of anterior and posteriorleaflet tissue coapting together during systole. As another example,some patients have a relatively large valve orifice (e.g., the orificemay dilate over time due to illness), and as a result are prone to lessleaflet coaptation and increased regurgitation. Ensuring sufficientcoaptation is addressed by various embodiments described herein,including the following examples.

While various embodiments described above include interlacing cordsextending from implants deployed near the free edge of mitral valveleaflets to perform an edge-to-edge or Alfieri procedure, in someimplementations, the implants can be alternatively or additionallydeployed in other locations to facilitate other types of cardiac repairsnecessitated by various cardiac issues (e.g., small posterior leaflet,large orifice, leaflet clefts, etc.), some of which are described below.

In some embodiments, for example, the implants can be placed near thefree edge of the anterior and posterior leaflets, and the cordsextending therefrom can be interlaced using the methods and devicesdescribed above to improve coaptation of the anterior and posteriorleaflets. For example, in a patient who has a relatively large valveorifice (e.g., due to dilation of the orifice over time due to illness),and as a result is prone to less leaflet coaptation and increasedregurgitation, approximating the implants can increase available leafletsurfaces for coaptation. Additionally, the interlaced cord can besuitably tensioned and/or pulled towards the access site and into theventricle of the heart, resulting in a larger surface area ofcoaptation, and improved coaptation between the leaflets.

Further, to promote a larger surface of coaptation, in some embodiments,implants can be deployed in the body of the leaflets and/or at or nearthe annulus of the anterior and posterior leaflets, and the cordsextending therefrom can be interlaced to pull or otherwise move theposterior annulus towards the anterior leaflet and/or the anteriorannulus towards the posterior leaflet, thereby reducing the distancebetween the anterior annulus and the posterior annulus, e.g., theseptal-lateral distance, by about 10%-40%. Said another way,approximating the anterior annulus and the poster annulus in this mannercan decrease the valve orifice, and thereby decrease, limit, orotherwise prevent undesirable regurgitation.

While various embodiments described herein have included two implantsand two sets of cords, in various implementations, any suitable numberof implants and any suitable number of sets of cords can be delivered,deployed, and interlaced to approximate various portions of the heart tocombat the cardiac issues described herein. For example, in someembodiments, three or more sets of cords can be twisted or interlaced toapproximate three or more implants. In some instances, for example, theheart can be effectively re-shaped (e.g., improve orifice geometry,improve relative leaflet geometry, etc.) by strategically deployingmultiple implants and securing multiple cords extending therefrom usingthe methods and devices described herein.

As another example, in some instances, it may be desirable to decrease agap between a valve commissure (e.g., the edge of the valve where theleaflets come together). In such instances, a first implant can bedeployed on the posterior leaflet near the commissure and a secondimplant can be deployed on the anterior leaflet near the commissure.With both the first implant and second implant deployed in this manner,the cords extending therefrom can be interlaced to approximate the firstimplant and the second implant such that the gap between the commissureis limited, decreased, or eliminated.

As another example, in some instances in which a patient has a cleftedleaflet, two or more implants can be deployed on either side of thecleft. The cords extending therefrom can then be interlaced toapproximate the implants such that the cleft in the leaflet is limited,decreased, or eliminated.

As another example, the valve annulus and/or orifice can be optimizedand/or reduced in size by deploying multiple anchors and cords extendingtherefrom in various locations within the heart to effectively deliverthe equivalent of an additional papillary muscle or a prostheticpapillary muscle (PPM). Such an embodiment is illustrated in FIG. 13using, as an example, the twister device 340 described above withrespect to FIGS. 10A-10J. As shown, six implants 331 are deployed to themitral valve, and all the cords extending from the six implants 331 areinterlaced to effectively create a single anchor common to all of thecords. Deploying multiple implants and securing or approximating thecords in this manner can provide the functionality otherwise provided bya properly functioning papillary muscle.

In some embodiments, a plurality of cords with implants at distal endsthereof can be attached to the posterior leaflet. In such embodiments,one or more of the sutures extending from the implants can be twisted,intertwined, or interlaced using the methods and devices describedherein. Similarly, in such embodiments, any portion of the suturesextending from implants in the posterior leaflet can be twisted,intertwined, or interlaced using the methods and devices describedherein, wherein the portion can be more than one suture, less than allof the sutures, or all of the sutures. A plurality of chords can beattached to the posterior leaflet to reduce cord failures by creating athicker, stronger base.

In some embodiments, a plurality of cords with implants at distal endsthereof can be attached to the anterior leaflet. In such embodiments,one or more of the sutures extending from the implants can be twisted,intertwined, or interlaced using the methods and devices describedherein. Similarly, in such embodiments, any portion of the suturesextending from implants in the anterior leaflet can be twisted,intertwined, or interlaced using the methods and devices describedherein, wherein the portion can be more than one suture, less than allof the sutures, or all of the sutures. A plurality of chords can beattached to the anterior leaflet to reduce cord failures by creating athicker, stronger base.

In some embodiments, a plurality of cords with implants at distal endsthereof can be attached to both the anterior leaflet and the posteriorleaflet. In such embodiments, one or more of the sutures extending fromthe implants can be twisted, intertwined, or interlaced using themethods and devices described herein. Similarly, in such embodiments,any portion of the sutures extending from implants in the anteriorleaflet and the posterior leaflet can be twisted, intertwined, orinterlaced using the methods and devices described herein, wherein theportion can be more than one suture, less than all of the sutures, orall of the sutures.

The above-described procedures can be performed manually, e.g., by aphysician, or can alternatively be performed fully or in part withrobotic or machine assistance. For example, in some embodiments, atwister device can be configured to twist automatically to provide thedesirable amount of interlacing. Further, although not specificallydescribed for some embodiments, in various embodiments, the heart mayreceive rapid pacing to minimize the relative motion of the edges of thevalve leaflets during the procedures described herein (e.g., while thesutures are being interlaced).

ADDITIONAL EMBODIMENTS AND TERMINOLOGY

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations. The embodimentsdescribed herein can include various combinations and/orsub-combinations of the functions, components and/or features of thedifferent embodiments described.

The present disclosure describes various features, no single one ofwhich is solely responsible for the benefits described herein. It willbe understood that various features described herein may be combined,modified, or omitted, as would be apparent to one of ordinary skill.Other combinations and sub-combinations than those specificallydescribed herein will be apparent to one of ordinary skill, and areintended to form a part of this disclosure. Various methods aredescribed herein in connection with various flowchart steps and/orphases. It will be understood that in many cases, certain steps and/orphases may be combined together such that multiple steps and/or phasesshown in the flowcharts can be performed as a single step and/or phase.Also, certain steps and/or phases can be broken into additionalsub-components to be performed separately. In some instances, the orderof the steps and/or phases can be rearranged and certain steps and/orphases may be omitted entirely. Also, the methods described herein areto be understood to be open-ended, such that additional steps and/orphases to those shown and described herein can also be performed.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense, as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to.” The word “coupled”, as generally usedherein, refers to two or more elements that may be either directlyconnected, or connected by way of one or more intermediate elements.Additionally, the words “herein,” “above,” “below,” and words of similarimport, when used in this application, shall refer to this applicationas a whole and not to any particular portions of this application. Wherethe context permits, words in the above Detailed Description using thesingular or plural number may also include the plural or singular numberrespectively. The word “or” in reference to a list of two or more items,that word covers all of the following interpretations of the word: anyof the items in the list, all of the items in the list, and anycombination of the items in the list.

The disclosure is not intended to be limited to the implementationsshown herein. Various modifications to the implementations described inthis disclosure may be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. The teachings of the invention provided herein can beapplied to other methods and systems, and are not limited to the methodsand systems described above, and elements and acts of the variousembodiments described above can be combined to provide furtherembodiments. Accordingly, the novel methods and systems described hereinmay be embodied in a variety of other forms; furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made without departing from the spiritof the disclosure. The accompanying claims and their equivalents areintended to cover such forms or modifications as would fall within thescope and spirit of the disclosure.

What is claimed is:
 1. A twister device comprising: a body; a suturemanagement component coupled to the body, the suture managementcomponent having one or more features to receive end portions of two ormore sutures and to secure the received suture end portions to the body;and a twisting component coupled to the body, the twisting componentconfigured to rotate the suture management component to intertwine thetwo or more sutures.
 2. The twister device of claim 1, wherein thesuture management component includes two or more tie knobs.
 3. Thetwister device of claim 2, wherein the suture management componentfurther includes suture locks configured to releasably engage with thetwo or more tie knobs to secure the suture end portions to the two ormore tie knobs.
 4. The twister device of claim 2, wherein the tie knobsinclude components that extend laterally relative to the body.
 5. Thetwister device of claim 2, wherein the tie knobs extend distallyrelative to the body.
 6. The twister device of claim 2, wherein the tieknobs are positioned symmetrically about a rotation axis of the suturemanagement component.
 7. The twister device of claim 1, wherein thesuture management component includes a rotating spin lock.
 8. Thetwister device of claim 7, wherein the rotating spin lock includes anadjustable leak proof seal configured to grip the suture end portionsand to prevent backflow of fluids during operation of the twisterdevice.
 9. The twister device of claim 1 further comprising a side portconfigured to receive a fluid to prevent blood from clotting.
 10. Thetwister device of claim 1, wherein the body forms a lumen configured toallow two or more sutures to pass therethrough.
 11. The twister deviceof claim 10, wherein the suture management component is formed on aproximal side of the body and the lumen runs from the proximal side tothe distal side of the body.
 12. The twister device of claim 11 furthercomprising a valve at a distal end of the lumen, the valve configured tolimit backflow of fluids out of the lumen.
 13. The twister device ofclaim 11, wherein the suture management component is configured tosecure the received suture end portions that are routed from the distalside to the proximal side of the body through the lumen.
 14. The twisterdevice of claim 13, wherein the body forms a first hole and a secondhole at a distal end of the body, the first hole and the second holeconfigured to provide entry to a distal end of the lumen for the two ormore sutures.
 15. The twister device of claim 1, wherein the twistingcomponent is integrally formed with the suture management component. 16.The twister device of claim 1, wherein the suture management componentis configured to rotate relative to the twisting component, rotation ofthe suture management component being controlled by the twistingcomponent.
 17. The twister device of claim 1, wherein the body isconfigured to cooperate with a valved-introducer to gain access to aregion within a patient.
 18. The twister device of claim 1, wherein thetwo or more sutures are attached to a valve in a heart of a patient. 19.The twister device of claim 18, wherein intertwining the two or moresutures causes leaflets of the valve to approximate.
 20. The twisterdevice of claim 1, wherein intertwining the two or more sutureseffectively creates a single anchor common to the two or more sutures.